—#51475

Product

Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; catalog no. 11972103122.

FDA product code: CEW — Radioimmunoassay, Parathyroid Hormone
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K992680
Affected lot / code info: Lots 17723501, exp. 1/31/08; 17723502, exp. 1/31/08; 17642601, exp. 11/30/07; 17642602, exp. 11/30/07; 17450901, exp. 5/31/07; 17450902, exp. 5/31/07 and 17450903, exp. 5/31/07.

Why it was recalled

Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.

Root cause (FDA determination)

Other

Action the firm took

The firm issued a letter dated 04/19/07 to all users informing them of the change in the hemoglobin interference claim.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46250-0416

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2007-04-19
Posted by FDA: 2007-05-16
Terminated: 2008-06-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #51475. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.